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Siemens Atellica CH Aspartate Aminotransferase P5P (ASTPLc) - HSA Registration DE0509613

Access comprehensive regulatory information for Siemens Atellica CH Aspartate Aminotransferase P5P (ASTPLc) in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0509613 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on August 02, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B IVD
DE0509613
Siemens Atellica CH Aspartate Aminotransferase P5P (ASTPLc)
HSA Registration Number: DE0509613
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Product Description

The Atellicaยฎ CH Aspartate Aminotransferase P5P (ASTPLc) assay is for in vitro diagnostic use in the quantitative determination of aspartate aminotransferase activity in human serum and plasma (lithium heparin) on the Atellicaยฎ Analyzer. This assay is used to aid in the diagnosis and treatment of certain types of liver and heart disease.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0509613
Registration Date
August 02, 2024
Retention Due Date
August 01, 2025
Product Owner
Short Name
Siemens Healthcare, USA
Address
511 Benedict Avenue, Tarrytown, NY 10591, UNITED STATES
Registrant
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model Information
Model Name(s)
Atellica CH Aspartate Aminotransferase P5P (ASTPLc) Atellica CH ENZ 2 Calibrator (ENZ 2 CAL)
Model Identifier(s)
11097639 11099318